- Lilly (Concord, NC)
- …service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include ... develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically… more
- Lilly (Concord, NC)
- … Lead roles are expected to become the leaders for the PAR equipment and process and will lead the training of new staff. This position will require travel ... now is the perfect opportunity! During the project phase, the Parenteral (PAR) Lead Operator will support start up activities required to bring the area into… more
- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Lead Associate 2, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology ... audits and regulatory inspections as an assay or method Subject Matter Expert (SME) + Ensures laboratory maintains inspection readiness, data integrity, and Current… more
- Novo Nordisk (Clayton, NC)
- …(FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, ... the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the...DI and compliance for their projects, systems, etc. + Lead discussions in the DI and compliance space +… more
- Merck (Durham, NC)
- …and exciting facility will have the unique opportunity to give input in the design process , startup their areas, and lead the teams to full production. Our ... not limited to:** _Project Support_ + Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of… more
- Kelly Services (Winston Salem, NC)
- …levels of quality and compliance. **Essential Duties & Responsibilities:** + Lead and oversee cell processing activities, ensuring compliance with industry standards ... batch records, and related forms, maintaining compliance with regulatory guidelines. + Lead routine cycle counts and ensure accurate inventory tracking and control.… more
- Novo Nordisk (Clayton, NC)
- …Join Team Novo Nordisk and help us make what matters. The Position Serve as process subject matter expert (SME) for assigned CMO production/ process area. ... operations areas to meet business and regulatory. Serve as lead and mentor/trainer for junior team members, to include...Good knowledge of overall practices for drug product manufacturing, aseptic filling process , quality management systems a… more
- Lilly (Concord, NC)
- …qualification, and validation of the Parenteral (PAR) areas as well as lead / assist in operations readiness programs (eg Material procurement and definition, ... training programs, process excellence, continuous improvement, and capacity planning). The PAR...The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. The… more
- Kelly Services (Clayton, NC)
- …+ Author, review, and approve department SOPs, reports, and investigations. + Lead process improvements through change control and continuous improvement ... compliance, employee development, staffing, training, and budget. **Primary Responsibilities:** + Lead and manage all aspects of the QC Environmental Monitoring… more
- Lilly (Concord, NC)
- …training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start-up, and validation of the parenteral (PAR) ... areas which include formulation, aseptic filling, and visual inspection areas. This position is...The Senior Manager, Parenteral Operations (Nights) is expected to lead by example and provide coaching to others in… more